Depression Clinical Trial
Official title:
The Effectiveness and Cost-effectiveness of Implementing Evidence-based Depression Treatment Within the TB Care Platform in South Africa: A Hybrid Effectiveness-implementation Trial
This hybrid type I effectiveness-implementation trial will increase understanding of the effectiveness and cost-effectiveness of integrating a brief evidence-based treatment for major depressive disorder (MDD) within the tuberculosis (TB) care platform to improve TB and MDD. Findings from this R01 are likely to inform policy and treatment guidelines for the integrated management of TB and MDD in low- and middle-income countries globally.
Status | Recruiting |
Enrollment | 1410 |
Est. completion date | September 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or over - initiating treatment for TB - ability to provide informed consent Exclusion Criteria: - unable or unwilling to provide informed consent |
Country | Name | City | State |
---|---|---|---|
South Africa | Desmond Tutu HIV Foundation | Cape Town |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Columbia University, Desmond Tutu HIV Foundation, National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TB treatment success rate | Patient level TB treatment success (yes/no) will be extracted from clinic records and defined based on the South African National TB Control Guidelines as all smear-positive patients that were cured (negative smear in last month of treatment) and those that completed treatment but did not meet the criteria for cure or failure. | 6 months | |
Secondary | Depression remission rate | Patient level depression remission (yes/no) will be assessed using the Patient Health Questionnaire (PHQ-9) and defined as a score less than 10. | 2 months, 6 months |
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